1. Field of the Invention
This invention is in the field of surgical instruments and more particularly in the field of vessel dilators.
2. Related Art
A leading cause of mortality and morbidity of surgical patients is hospital borne disease transmission between patients. There are many machines and procedures for sterilizing and cleaning surgical instruments, including autoclaving. Despite the severity and rigor of these machines and procedures, the cleaning of the instruments is less than optimal. Specifically, blood denatures and hardens in crevices or embeds onto restricted areas of an instrument such that there are deposits of blood that remain after cleaning. These deposits of blood that remain after cleaning contain live pathogens. The result being that there is a risk of the transmission of disease from patient to patient.
It is theorized that humankind will never be able to devise a machine and/or process that in an economical and practical manner will optimally clean surgical instrument. Accordingly, it would be desirable to have surgical instrument that are disposable without compromising the efficacy and the cost effectiveness of performing surgery.
One type of surgical instrument is a vessel dilator. As the name implies, a vessel dilator provides intra-luminal vessel dilation during surgery. Vessel dilators are frequently used during surgical procedures as aid in fine dissection and vessel anastomosis. A conventional vessel dilator can be conceptualized as a modified forceps having elongated parallel tips which are highly polished. The parallel tips are pressed together to provide a single tapered shaft. The tapered shaft is inserted into a vessel and the parallel tips are allowed to separate thereby dilating the vessel. As a vessel dilator is inserted into a vessel, the dilator helps to hold the vessel wall and to avoid suturing the back wall to the front wall of the vessel.
Another type of surgical instrument is an irrigation instrument. Often, when a vessel is to be sutured, the vessel must be irrigated using an irrigation instrument. Irrigation is used to prevent drying of tissue, to remove tissue debris and blood, to keep vessel ends open and prevent floating adventitia at vessel ends interrupting satisfactory microvascular suturing and anastomosis. Irrigation keeps the operative field clean and inhibits blood clotting inside the lumen of the blood vessel.
Another type of surgical instrument is a suction instrument. Suction keeps the operative field clean and inhibits blood clotting inside the lumen of the blood vessel.
Another type of surgical devise is a cauterization instrument. Cauterization seals vessels and arrest bleeding. One conventional cauterization instrument is a bipolar-type blood vessel coagulation/stanching devise. Such a conventional devise employs a spark gap methodology using high-frequency current ranging between 0.5 to 3 MHz. This bipolar type devise has two electrodes (active and inactive electrodes) which are provided at both ends of a pair of forceps that are held by hand. Electric current flows only through the living tissue held between the ends of the forceps. Since electric current to a patient is applied only to a limited portion to be coagulated, bleeding from a blood vessel can be stopped completely without injuring other tissues. More specifically, the cauterization effect of the devise is obtained by coagulating the blood vessel using localized heating caused by the high-frequency current flowing through the living tissue.
Another surgical procedure of relevance here is anastomosis. Anastomosis covers a variety of procedures in which blood vessels (or other tubular members) are joined or reconnected. Vessels may be joined in a variety of relative orientations, including end-to-side and end-to-end. Anastomosis is traditionally performed by suturing the vessels together at the juncture between them. Alternatives to suturing have been developed, in order to prevent thrombosis which tends to occur at the points of penetration of the sutures. One such alternative, particularly for larger vessels, involves mechanical connectors such as collars. A second alternative is the use of surgical clips which are applied along the vessel juncture to perform a holding function similar to that of sutures, without penetrating the vessel walls.
A surgeon alternates amongst dilation, irrigation, suction and cauterization, during vessel dissection and anastomosis, using separate dilation, suction, irrigation and cauterization instruments. The act of switching among these four instruments is time-consuming and can interrupt the surgeon's attention and concentration.
In Bayat, A., A Novel, Triple-Function Vessel Dilator, Plastic And Reconstructive Surgery, January, 2003, volume 111(1), pp. 501-502 (American Society of Plastic Surgeons) and in Bayat, A. et al., A Novel Irrigating Vessel Dilator for Microsurgery, Plastic and Reconstructive Surgery, September, 2001, Vol 108(3), pp. 798-799, Applicant herein invented a three functional vessel dilator performing the functions of dilation, irrigation and suction during vessel dissection and anastomosis. Still, when suturing a blood vessel or otherwise performing operative tasks, a surgeon must alternate between this three functional vessel dilator and a cauterization instrument. Alternating between these two instruments is time consuming and interrupts the surgeon's attention.
In patent application Ser. No. 11/471,067 upon which this application is a continuation-in-part and which is incorporated herein by reference as further referred to herein below, there is taught the ingenuity of a four function microsurgical instrument performing the functions of aspiration, irrigation, dilation and cauterization in a novel and unobvious design. Referring to FIG. 1 of application Ser. No. 11/471,067, the instrument has a body with forceps-like arms. A plunger valve extends perpendicular from the body in a direction away from a side region and is positioned for actuation by a user (see, FIG. 1, reference numerals 12 and 30). This ingenuous design advanced the art; but, there were stell needs for an instrument with even more enhanced ergonomics, better stability, ease of use and use which did require repositioning of a user's finger from gripping a forceps-like arm to contacting a plunger valve so at to actuate the valve.
Accordingly, there exists a need for an all-in-one, simple to use, easy to handle, lightweight, atraumatic macrosurgery and/or microsurgical instrument that improves the overall efficiency of operative procedures. There exists a need for a surgical instrument configured so that all the four functions of dilation, suction, irrigation and cauterization fit together in one instrument and enabling a surgeon to perform operative tasks without having to switch instruments. There is therefore a need for a four function vessel dilator performing the functions of dilation, irrigation, suction and cauterization for use, including, during vessel dissection and anastomosis. There exists a need for an instrument for microsurgery that provides the advantages of being small in size, being ergonomical, being all-in-one, eliminating the need for a surgeon to fumble around in switching between instruments, reducing time consumption and reducing frustration.
There exists a need for a surgical instrument possessing the functions of dilation, irrigation, aspiration and cauterization where the user is NOT required to reposition and move the user's finger from gripping a forceps-like arm to the finger contact area of an actuation means for controlling irrigation-fluid and aspiration-suction.
There exists a further need for a surgical instrument possessing the functions of dilation, irrigation, aspiration and cauterization where the mechanism for controlling irrigation-fluid and aspiration-suction occupies a small and minimized volume such that it is containable in an instrument for microsurgery.
There exists a further need for a surgical instrument possessing a valve that has a high level of ergonomics; in particular, there would be a biometrically comfortable force to actuate the valve, a short travel distance for actuation, non-awkward finger positioning and a high level of instrument support within the hand.
There is a need for a totally disposable instrument that is low in cost and avoids the transmission of pathogenic agents, because current sterilization techniques are not totally fail-safe.
The present invention satisfies these needs, as well as others, and generally overcomes the presently known deficiencies in the art.